Donald Trump, AP

Fed­er­al judge scut­tles Trump's rule man­dat­ing drug prices in TV ads

The Trump ad­min­is­tra­tion has en­dured a set­back af­ter a fed­er­al court over­turned a rul­ing — oblig­at­ing drug man­u­fac­tur­ers to dis­close the list price of their ther­a­pies in tele­vi­sion ad­verts — hours be­fore it was stip­u­lat­ed to go in­to ef­fect.

In May, the HHS pub­lished a fi­nal rul­ing re­quir­ing drug­mak­ers to di­vulge the whole­sale ac­qui­si­tion cost— of a 30-day sup­ply of the drug — in tv ads in a bid to en­hance price trans­paren­cy in the Unit­ed States. The phar­ma­ceu­ti­cal in­dus­try has ve­he­ment­ly op­posed the rule, as­sert­ing that list prices are not what a typ­i­cal pa­tient in the Unit­ed States pays for treat­ment — that num­ber is typ­i­cal­ly de­ter­mined by the type of (or lack there­of) in­sur­ance cov­er­age, de­ductibles and out-of-pock­et costs. Al­though there is truth to that claim, the move was con­sid­ered sym­bol­ic in the Trump ad­min­is­tra­tion’s health­care agen­da to hold drug­mak­ers ac­count­able in a cli­mate where sky­rock­et­ing drug prices have in­censed Amer­i­cans on both sides of the aisle.

The suit, va­cat­ed by a DC fed­er­al judge on Mon­day, was brought on by a tri­fec­ta of drug­mak­ers: Mer­ck $MRK, Eli Lil­ly $LLY and Am­gen $AMGN, in ad­di­tion to the Na­tion­al As­so­ci­a­tion of Ad­ver­tis­ers, a trade as­so­ci­a­tion. They ar­gued that the rule eclipsed HHS’s au­thor­i­ty be­cause Con­gress “nei­ther ex­press­ly nor im­plied­ly grant­ed HHS the pow­er un­der the So­cial Se­cu­ri­ty Act to reg­u­late drug mar­ket­ing” and con­tend­ed that com­pelled speech vi­o­lat­ed the First Amend­ment.

The court agreed that the HHS does not have the statu­to­ry au­thor­i­ty to im­ple­ment the drug price dis­clo­sure rul­ing. Al­though the court does not take “any view on the wis­dom of re­quir­ing drug com­pa­nies to dis­close prices. That pol­i­cy very well could be an ef­fec­tive tool in halt­ing the ris­ing cost of pre­scrip­tion drugs. But no mat­ter how vex­ing the prob­lem of spi­ral­ing drug costs may be, HHS can­not do more than what Con­gress has au­tho­rized,” it con­clud­ed.

The Amer­i­can As­so­ci­a­tion of Re­tired Per­sons (AARP), a non-prof­it or­ga­ni­za­tion that ad­vo­cates for the el­der­ly, said it was dis­ap­point­ed by the court’s de­ci­sion.

Nan­cy Lea­Mond AARP

“High drug prices dis­pro­por­tion­ate­ly hurt old­er Amer­i­cans, par­tic­u­lar­ly Medicare Part D en­rollees who take an av­er­age of 4.5 pre­scrip­tion med­ica­tions each month. Most Medicare ben­e­fi­cia­ries live on fixed in­comes, with a me­di­an an­nu­al in­come of just over $26,000,” AARP ex­ec­u­tive VP and chief ad­vo­ca­cy and en­gage­ment of­fi­cer Nan­cy Lea­Mond said in a state­ment. “To­day’s rul­ing is a step back­ward in the bat­tle against sky­rock­et­ing drug prices and pro­vid­ing more in­for­ma­tion to con­sumers. Amer­i­cans should be trust­ed to eval­u­ate drug price in­for­ma­tion and dis­cuss any con­cerns with their health care providers.”

Trump has long lam­bast­ed the phar­ma­ceu­ti­cal in­dus­try for its pric­ing poli­cies. Af­ter cap­tur­ing the pres­i­den­cy, Trump pro­claimed drug­mak­ers were “get­ting away with mur­der.” His ad­min­is­tra­tion has since un­veiled a string of pro­pos­als to tem­per pric­ing, in­clud­ing one last year en­gi­neered to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries.

As he mounts his re-elec­tion bid for 2020, Trump sug­gest­ed on Fri­day that an ex­ec­u­tive or­der is be­ing pre­pared to im­ple­ment a “fa­vored na­tions clause” to re­duce drug prices in the Unit­ed States, in con­ver­sa­tion with re­porters on the south lawn of the White House.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.